A Randomized Trial of Short-Course Preemptive Ganciclovir Compared with Conventional Ganciclovir Therapy To Prevent Cytomegalovirus Infection after Allogeneic Stem Cell Transplantation.

We studied the efficacy and safety of a short course of ganciclovir to prevent cytomegalovirus (CMV) infection in allogeneic hematopoietic stem cell transplantation (HSCT) recipients. In general, preemptive ganciclovir is administered twice daily for 1–2 weeks (induction phase) and then once daily until 6 days after cessation of viremia and antigenemia (maintenance phase). We randomly assigned allogeneic HSCT recipients who had positive shell vial culture for CMV or CMV antigenemia to receive preemptive ganciclovir therapy with or without induction phase (5 mg/kg body weight, twice a day for one week). 32 and 34 patients were randomized to the standard treatment arm and the short course arm, respectively. There were no statistically significant differences in patient characteristics such as age, sex, type of disease, type of transplantation, seropositivity of CMV antibody in donor, seropositivity of CMV antibody in recipient, type of conditioning regimen or GVHD prophylaxis regimen between two groups. The median time to clearance of CMV viremia and antigenemia was 7 d and 9 day, respectively (P = 0.333). Seven patients in the short course arm failed for viral clearance after preemptive therapy and were cross-overed to the standard preemptive therapy, which resulted in clearance of antigenemia and viremia in all patients. The toxicity profile was higher in the standard treatment arm with 5 neutropenia and 1 drug-induced hepatitis whereas there was only 1 neutropenia in the short-course arm. Of 5 patients who experienced neutropenia, 2 died of sepsis. This study shows that the preemptive ganciclovir therapy with maintenance phase alone may be equally effective to the standard treatment arm with less toxicity profile in prevention of CMV disease in allogeneic HSCT recipients. The omission of induction phase in CMV preemptive therapy may allow patients to avoid unnecessary hospital admissions.